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FDA 510(k)

SPQ(TM) TEST SYSTEM FOR PREALBUMIN

K-Number: K884297 · 1988-11-02

ApplicantAtlantic Antibodies
Decision Date1988-11-02
Product CodeJZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) TEST SYSTEM FOR PREALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1988-11-02 under 510(k) number K884297. The device is classified under product code JZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ(TM) TEST SYSTEM FOR PREALBUMIN?

SPQ(TM) TEST SYSTEM FOR PREALBUMIN is a medical device that received FDA 510(k) clearance on 1988-11-02. The listed applicant is Atlantic Antibodies. The 510(k) number is K884297.

When did SPQ(TM) TEST SYSTEM FOR PREALBUMIN receive FDA 510(k) clearance?

SPQ(TM) TEST SYSTEM FOR PREALBUMIN received FDA 510(k) clearance on 1988-11-02, under 510(k) number K884297.

Who is the listed applicant for SPQ(TM) TEST SYSTEM FOR PREALBUMIN?

The FDA 510(k) record lists Atlantic Antibodies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPQ(TM) TEST SYSTEM FOR PREALBUMIN?

The FDA product code for SPQ(TM) TEST SYSTEM FOR PREALBUMIN is JZJ.

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Other records listing Atlantic Antibodies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K892526SPQ TM TEST SYSTEM II FOR CRPK891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BK890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

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Related Devices (Code: JZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000661RANDOX PREALBUMINRandox Laboratories, Ltd.K972638TINA-QUANT PREALBUMINBoehringer Mannheim Corp.K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K913672PREALBUMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K884298SPQ(TM) TEST SYSTEM FOR MICROALBUMINAtlantic AntibodiesK883002QM300 PREALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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